PMA P970003S153
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S153
- Product code
- MUZ
- Decision date
- 2012-10-30
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- CHANGE AND THE USE OF ALTERNATE COMPONENTS ON THE PRINTED CIRCUIT BOARD FOR THE PROGRAMMING WAND.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S153
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2012-10-30
- Decision code
- OK30
- Date received
- 2012-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE AND THE USE OF ALTERNATE COMPONENTS ON THE PRINTED CIRCUIT BOARD FOR THE PROGRAMMING WAND.